Nasopore Nasal Dressing (Stryker) – Packaging Seal Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Brand
Stryker Corporation
Lot Codes / Batch Numbers
5400-010-004 UDI-DI: 07613154340798, 5400-010-004ITL UDI-DI: 07613327359435
Products Sold
5400-010-004 UDI-DI: 07613154340798, Lot Numbers: 2022101814 2023021412 2023082413 2024022915 2022111414 2023051712 2023090114 2022102413 2023022133 2023090613 2024031915 2023011013 2023052415 2023110315 2022111413 2023050913 2023091912 2024032215 2023011913 2023061615 2023112314 2023011613 2023051213 2023103115 2024040214 2023020113 2023062132 2024011912 2023012413 2023071713 2023110812 2024052915 2023020333 2023062615 2024020813 2023012713 2023080812 2023112018 2024062412 2023020612 2023062915 2024080117 2023020912 2023081112 2024011613 2024080912 2023050414 2023070433 2024082216; 5400-010-004ITL UDI-DI: 07613327359435, Lot Numbers: 2022111414 2023051712 2023090114 2023011013 2023052415 2023110315 2023011913 2023061615 2023112314 2023020113 2023062132 2024011912 2023020333 2023062615 2024020813 2023020612 2023062915 2024080117 2023050414 2023070433 2024082216
Stryker Corporation is recalling Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL due to There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Recommended Action
Per FDA guidance
An Urgent Medical Device Recall notification letter dated 2/24/25 was sent to customers. Actions to be taken 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email Instruments.Recalls@stryker.com. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement will be provided upon receipt of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Instruments.recalls@stryker.com. RESPONSE IS REQUIRED.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026